 | |
| Clinical data | |
|---|---|
| Trade names | Orladeyo |
| Other names | BCX7353, BCX-7353 |
| License data |
|
|
Routes of administration | By mouth |
| Drug class | Plasma kallikrein inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number |
|
| PubChem CID | |
| DrugBank | |
| ChemSpider | |
| UNII |
|
| KEGG | |
| CompTox Dashboard ( EPA) | |
| Chemical and physical data | |
| Formula | C30H26F4N6O |
| Molar mass | 562.573 g·mol−1 |
| 3D model ( JSmol) | |
| |
| |
Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema (HAE) in people aged twelve years and older. [3] [5] [7] [8] [4]
The most common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn. [4]
Berotralstat was approved for medical use in the United States in December 2020, [3] [4] [9] and in the European Union in April 2021. [5]
Berotralstat was approved based on evidence from one clinical trial (Trial 1 /NCT03485911) of 120 participants with hereditary angioedema. [4] The trial was conducted at 40 sites in the United States, the European Union, and Canada. [4] Trial investigators evaluated participants 12 years and older [10] with hereditary angioedema for eight weeks to determine the number of attacks for each participant. [4] The trial enrolled only participants who had at least two attacks during the eight-week period. [4] Participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks. [4] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed. [4] All participants could use other medications for treatment of attacks. [4]
- ^ "Summary Basis of Decision - Orladeyo". Health Canada. 23 October 2014. Retrieved 28 November 2022.
- ^ Product monograph hres.ca
- ^ a b c "Orladeyo- berotralstat hydrochloride capsule". DailyMed. Retrieved 25 December 2020.
- ^
a
b
c
d
e
f
g
h
i
j
k
"Drug Trials Snapshot: Orladeyo". U.S. Food and Drug Administration. 3 December 2020. Retrieved 25 December 2020.
This article incorporates text from this source, which is in the
public domain.
- ^ a b c "Orladeyo EPAR". European Medicines Agency (EMA). 24 February 2021. Retrieved 12 July 2021.
- ^ "Orladeyo Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ Hwang JR, Hwang G, Johri A, Craig T (December 2019). "Oral plasma kallikrein inhibitor BCX7353 for treatment of hereditary angioedema". Immunotherapy. 11 (17): 1439–1444. doi: 10.2217/imt-2019-0128. PMID 31635497.
- ^ Zuraw B, Lumry WR, Johnston DT, Aygören-Pürsün E, Banerji A, Bernstein JA, et al. (October 2020). "Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial". The Journal of Allergy and Clinical Immunology. 148 (1): 164–172.e9. doi: 10.1016/j.jaci.2020.10.015. PMID 33098856.
- ^ "Orladeyo: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 December 2020.
- ^ "Berotralstat (Oral Route) Side Effects - Mayo Clinic". www.mayoclinic.org. Retrieved 3 March 2021.
- "Berotralstat". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT03485911 for "Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2)" at ClinicalTrials.gov
 | This drug article relating to the blood and blood forming organs is a stub. You can help Wikipedia by expanding it. |
|
| |
| Clinical data | |
|---|---|
| Trade names | Orladeyo |
| Other names | BCX7353, BCX-7353 |
| License data |
|
|
Routes of administration | By mouth |
| Drug class | Plasma kallikrein inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number |
|
| PubChem CID | |
| DrugBank | |
| ChemSpider | |
| UNII |
|
| KEGG | |
| CompTox Dashboard ( EPA) | |
| Chemical and physical data | |
| Formula | C30H26F4N6O |
| Molar mass | 562.573 g·mol−1 |
| 3D model ( JSmol) | |
| |
| |
Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema (HAE) in people aged twelve years and older. [3] [5] [7] [8] [4]
The most common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn. [4]
Berotralstat was approved for medical use in the United States in December 2020, [3] [4] [9] and in the European Union in April 2021. [5]
Berotralstat was approved based on evidence from one clinical trial (Trial 1 /NCT03485911) of 120 participants with hereditary angioedema. [4] The trial was conducted at 40 sites in the United States, the European Union, and Canada. [4] Trial investigators evaluated participants 12 years and older [10] with hereditary angioedema for eight weeks to determine the number of attacks for each participant. [4] The trial enrolled only participants who had at least two attacks during the eight-week period. [4] Participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks. [4] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed. [4] All participants could use other medications for treatment of attacks. [4]
- ^ "Summary Basis of Decision - Orladeyo". Health Canada. 23 October 2014. Retrieved 28 November 2022.
- ^ Product monograph hres.ca
- ^ a b c "Orladeyo- berotralstat hydrochloride capsule". DailyMed. Retrieved 25 December 2020.
- ^
a
b
c
d
e
f
g
h
i
j
k
"Drug Trials Snapshot: Orladeyo". U.S. Food and Drug Administration. 3 December 2020. Retrieved 25 December 2020. This article incorporates text from this source, which is in the
public domain.
- ^ a b c "Orladeyo EPAR". European Medicines Agency (EMA). 24 February 2021. Retrieved 12 July 2021.
- ^ "Orladeyo Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ Hwang JR, Hwang G, Johri A, Craig T (December 2019). "Oral plasma kallikrein inhibitor BCX7353 for treatment of hereditary angioedema". Immunotherapy. 11 (17): 1439–1444. doi: 10.2217/imt-2019-0128. PMID 31635497.
- ^ Zuraw B, Lumry WR, Johnston DT, Aygören-Pürsün E, Banerji A, Bernstein JA, et al. (October 2020). "Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial". The Journal of Allergy and Clinical Immunology. 148 (1): 164–172.e9. doi: 10.1016/j.jaci.2020.10.015. PMID 33098856.
- ^ "Orladeyo: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 December 2020.
- ^ "Berotralstat (Oral Route) Side Effects - Mayo Clinic". www.mayoclinic.org. Retrieved 3 March 2021.
- "Berotralstat". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT03485911 for "Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2)" at ClinicalTrials.gov
|
| This drug article relating to the blood and blood forming organs is a stub. You can help Wikipedia by expanding it. |